Cipla, Formosa sign multi-regional licensing deal for Clobetasol Suspension
This partnership aims to enhance ophthalmic care by providing treatment for post- operative inflammation and pain in patients…
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Browsing Tag
USFDA
Lupin gains tentative USFDA approval for Amifampridine Tablets
Amifampridine Tablets, 10 mg, are bioequivalent to Firdapse Tablets, 10 mg of Catalyst Pharmaceuticals
Zydus receives final USFDA approval for Eluxadoline Tablets, 75 mg and 100 mg
Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea…
Zydus receives final USFDA approval for Ketoconazole Shampoo, 2%
Ketoconazole shampoo is an antifungal medication used to treat dandruff, fungal infections, and other skin conditions
Senores Pharma acquires 14 ANDAs from Dr. Reddy’s
The basket acquired comprises 13 ANDAs, which are approved by the USFDA and 1 ANDA, which is pending approval from the USFDA
USFDA approves novel non-opioid treatment for moderate to severe acute pain
Vertex Pharmaceuticals’ Journavx is the first drug to be approved in this new class of pain management medicines
OneSource gains EIR with VAI classification from USFDA for its BLD Facility
The report follows an inspection of the facility, conducted from November 14 to November 22, 2024
Novo Nordisk’s Ozempic gains USFDA approves to cut risk of diabetic kidney disease progression
The approval was based on data from a late-stage study, which showed that Ozempic helped cut the risk of death from chronic kidney…
Lupin gains USFDA approval for Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension
The fixed-dose combination is indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and…
India’s biopharma industry needs to become a little bit more ambitious
In a free wheeling conversation with Viveka Roychowdhury, Dr Dhananjay Patankar, biopharma consultant, explains why Indian…